Sterilization and Disinfection for Ambulatory …...3 Disinfection and Sterilization Standards and...

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1 Sterilization and Disinfection for Ambulatory Surgery Centers February 10, 2015 © 3M 2015 All Rights Reserved. House Keeping From the GoToWebinar page: Click on the orange box with a white arrow to expand your control panel (upper right- hand corner of your screen). Type a question in the question box and click send. © 3M 2015 All Rights Reserved. House Keeping Continuing Education Each 1 hour web meeting qualifies for 1 contact hour for nursing. 3M Health Care Provider is approved by the California Board of Registered Nurses CEP 5770. Post webinar email Link to Course Evaluation CE Certificate Included Forward eMail to Others in Attendance © 3M 2015 All Rights Reserved.

Transcript of Sterilization and Disinfection for Ambulatory …...3 Disinfection and Sterilization Standards and...

Page 1: Sterilization and Disinfection for Ambulatory …...3 Disinfection and Sterilization Standards and Recommendations AORN Guidelines for Perioperative Practice, 2015AAMI ST79 Comprehensive

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Sterilization and Disinfection for Ambulatory Surgery

Centers

February 10, 2015

© 3M 2015 All Rights Reserved.

House Keeping

From the GoToWebinar page:

Click on the orange box with a white arrow to expand your control panel (upper right-hand corner of your screen).

Type a question in the question box and click send.

© 3M 2015 All Rights Reserved.

House Keeping

Continuing EducationEach 1 hour web meeting qualifies for 1 contact hour for nursing. 3M Health Care Provider is approved by the California Board of Registered Nurses CEP 5770.

Post webinar email•Link to Course Evaluation

•CE Certificate Included

•Forward eMail to Others in Attendance

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Disclosure

Rose Seavey MBA, BS, RN, CNOR, CRCST, CSPDT

Educational Consultant to 3M Health Care

http://www.seaveyhealthcareconsulting.com/

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LEARNING OBJECTIVES

Identify the latest requirements and guidelines from accrediting organizations specifically relating to reprocessing of medical devices.

Describe key published standards & recommended practices for safe and effective reprocessing of reusable patient care items.

List available resources for best practice related to reprocessing of reusable medical devices.

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Equipment Reprocessing Lapses (CMS)

Approximately 25% of ASCs:•Single-use devices inappropriately reprocessed

•HLDs not prepared, tested, or replaced appropriately

• Instruments not precleaned prior to sterilization or HLD

•Monitoring devices (CIs or BIs) not appropriately used in sterilizer loads

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http://jama.ama-assn.org/content/303/22/2273.full

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Disinfection and Sterilization

Standards and Recommendations

AORN Guidelines for Perioperative Practice, 2015

AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 &A4:2013

AAMI ST58:2013 Chemical sterilization and high-level disinfection in health care facilities

CDC Guideline for Decontamination and Sterilization in Healthcare Facilities, 2008

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AORN RPs Sterilization and Disinfection

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Anesthesia Equipment – Cleaning and Disinfection

Disinfection – High Levels

Flexible Endoscopes – Cleaning and Processing

Instruments – Cleaning and Care of

Packaging Systems – Selection and Use

Sterilization

Customizable policy and procedure template available

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Competency Verification Tools and Job Descriptions

ROLE-SPECIFIC COMPETENCIES AND JOB DESCRIPTIONS:

• RN Manager

• Technician

PRACTICE-SPECIFIC:• HLD

• Endoscopes

• Instruments

• Packaging

• Sterilization-All Methods

• Sterilization-Steam

STERILIZATION COMPETENCIES:

• Steam

• Dry Heat

• Ethylene Oxide

• Low Temperature Hydrogen Peroxide Gas Plasma

• Low Temperature Hydrogen Peroxide Vapor

• Ozone

• Peracetic Acid

http://www.aorn.org/CompetencyTools/© 3M 2015 All Rights Reserved.

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CDC Guideline for Decontamination and Sterilization

Nationally recognized and are referenced by accreditation and professional organizations

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http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf

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July 2011 - CDC Guide CDC Checklist

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http://www.cdc.gov/HAI/pdfs/guidelines/Outpatient-Care-Guide-withChecklist.pdf

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POLLING QUESTION

Which of the following resources are available to employees in your department?

A. AORN Guidelines for Perioperative Practices, 2015 (most current guidelines)

B. AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities ANSI/AAMI ST79:2010 & a1:2010 &A2:2011 & A3:2012 & A4:2013 (most current standards)

C. Both of these

D. Neither of these

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Centers for Medicare and Medicaid Services

September 4, 2009 - CMS released a memo to state survey agency directors regarding sterilization practices.

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“If manufacturers’ instructions are not followed, then the outcome of the sterilizer cycle is guesswork, and the ASC’s practices should be cited as a violation of 42 CFR416.44(b)(5).” (CMS, 2009)

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Obtain and review manufacturers’ current instructions for use IFU

“Standard” cycles may not be sufficient

• Contact device MFR Quality Control or Regulatory Affairs

• Internet-based electronic copies www.oneSOURCEdocs.com

Ensure that they have the necessary resources to follow manufacturers’ IFU

HC Personnel Responsibilityfor Reusable Medical Devices

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IFU Discrepancies

According to CMS, the facilities infection control P&P should discuss what to do when there are IFU discrepancies between a manufacturer’s device and a manufacturers’ IFU for the sterilizer.

According to AAMI - “If differing instructions cannot be resolved and the instrument is urgently needed, the device manufacturer’s instructions must be followed”.

Office of Clinical Standards & Quality/Survey & Certification to State Survey Agency Directors on Patient Safety Initiative Pilot Phase-Revised Draft Surveyor Worksheets on May 18, 2011. Accessed 7/8/2012 at: http://www.apic.org/Resource_/TinyMceFileManager/Advocacy-PDFs/CMS_revised_hospital_surveyors_worksheets_5-18-12.pdf

http://www.aami.org/publications/standards/ST79_Immediate_Use_Statement.pdf

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Personnel Considerations

Reprocessing responsibilities only assigned to:◦Qualified individuals◦Demonstrated and documented competencies in all areas

(cleaning, decontamination, packaging, monitoring, sterilizing etc.)

All staff should be certified within 2 years

◦Certification helps develop• Basic level of understanding and knowledge

• Consistencies and standardization

• Professional element to the department

• Self-esteem, confidence and authority

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 4AORN Recommended Practices for Sterilization 2015

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Sterile Processing/Central Service Certification

CBSPD IAHCSMM

THE CERTIFICATION BOARD FOR STERILE PROCESSING AND DISTRIBUTION, INC.

• Independent and international certifying body

• Accredited by the National Commission for Certifying Agencies (NCCA)

• Educational books, seminars and tools

WWW.STERILEPROCESSING.ORG

INTERNATIONAL ASSOCIATION OF HEALTHCARE CENTRAL SERVICE MATERIEL MANAGEMENT

• International certifying body

• Associated with Purdue University

• Professional membership organization

• Educational books, on-line classes and tools

WWW.IAHCSMM.ORG

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Sterile Processing/Central Service Certification CBSPD IAHCSMM

EXAM OFFERED 4 TIMES YEAR2.5 HOUR TESTLASERGRADE/PSI OFFICIAL TEST SITECERTIFICATION EXPIRES IN 5 YEARSTYPES OF CERTIFICATION OFFERED

• CSPDT (Technicians)

• Supervisors

• Managers

• Surgical Instrument Techs

• Flexible GI Scope Techs

• Certified Ambulatory Surgery Sterile Processing Technician

EXAMS SCHEDULED ANYTIME3 HOUR TESTPARAMETRIC SITE-BASED TESTING

FACILITIESCERTIFICATION EXPIRES ANNUALLYTYPES OF CERTIFICATION OFFERED• CRCST (Technicians)

• CHL (Healthcare Leadership)

• CIS (Instrument Specialist)

• CCVS (Vendor Certification)

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Sterile Processing/Central Service Certification

CBSPD IAHCSMM

PRIOR TO TAKING THE EXAM•12 months full time employment in SPD,

or one of the following:

• Sterile Processing certification course,

• Related course and 6 months experience, or

• Sales or service in healthcare

PRIOR TO TAKING THE EXAM•400 hours hands-on experience plus one

of the following:

• On-line course,

• Distance learning course,

• Approved instructor course,

• Self study, or

• Challenge the exam

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Sterile Processing/Central Service Certification

CBSPD IAHCSMM

5 YEAR RENEWAL PROCESS

•Cost $100 US

•100 points of continuing education in 5 year period

•10 points awarded per year for working full time in SPD

www.sterileprocessing.org

ANNUAL RENEWAL

•Cost $50 US per year

•12 points of continuing education per year

• Additional 6 points required for CIS or CHL

www.iahcsmm.org

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Certified Ambulatory Surgery Sterile Processing Technician

CERTIFICATION REQUIREMENTS• 1 yr FT or PT equivalent experience, or• Completion of ambulatory surgery sterile

processing training course, or• Related allied health program and 6 months

experience, or• Completion of 12 months of healthcare product

sales or service related to the ambulatory surgery sterile processing profession

HTTP://WWW.STERILEPROCESSING.ORG/AMBULATORY.HTM#A1

ONLINE COURSE•ASC, doctor's offices, and dental clinics

AGENDA•Anatomy & Physiology

Microbiology

• Infection Control

•Decontamination

•Processing Patient Care Equipment

•Preparation, Packaging, & Instrumentation Sterilization

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Sterile Processing Attire• Clean scrubs provided by and donned at the facility

• All head and facial hair (except for eyebrows and eyelashes) should be completely covered with a surgical-type hair coveringSkull caps are not recommended

• Jewelry that cannot be contained or confined within the surgical attire should not be worn.

• Sterile processing should wear scrub attire that covers the arms while preparing and packaging items. *

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013

*2015 AORN Recommended Practice for Surgical Attire

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Attire for Decontamination

PPE

• Heavy-duty utility gloves, Not procedure or surgeons gloves

• Liquid-resistant covering with sleeves: Jumpsuit, apron with sleeves, or gown

• Any risk of splash or splatter Fluid-resistant face mask Eye protection

• Safety glasses wrap around the eye, or • Face shield

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 &A3:2012 & A4:2013, Section 4.5.1

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Leadership Standards and EPs

LD.04.01.11: The hospital makes space and equipment available as needed for the provision of care, treatment, and services.

• EP 2. The arrangement and allocation of space supports safe, efficient, and effective care, treatment, and services.

• Need for sufficient space to adequate reprocess

• EP 5. The leaders provide for equipment, supplies, and other resources.

SP must have sufficient resources to support OR demand.

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Design Considerations

Space proportioned to expected volume (3.3.1)

Floors and walls endure frequent cleaning (3.3.6.1)

Ceilings recessed and enclosed pipes (3.3.6.2)

Doors, windows and pass throughs closed (3.3.6.3)

Handwashing stations conveniently located in both clean, and decontamination areas (3.3.6.8)

Eye wash stations (3.3.8)• Within 10 seconds travel time

• Ability to flush for 15 minutes

• Water temp. 60-100ºF

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013

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Design Considerations

Traffic patterns (3.2.4)•Dirty to clean

•Restricted to authorized personnel

Temp and humidity - monitored and recorded daily•Temperature: 68-73°F clean; 60-65°F decontamination

• Fans not permitted in any processing area

•Humidity: 30-60% in work areas (20-60% OR)

Housekeeping - separate decontam cleaning supplies•Cleaned daily (same as in OR)

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013

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Functional area AirflowMinimum number of

air exchanges/hr.

Soiled/ decontamination

Negative (in) 10

Sterilizer loading/ unloading

Positive (out) 10

Restrooms/ housekeeping

Negative (in) 10

Preparation and packaging

Positive (out) 10, down-draft type

Clean/sterile storage Positive (out) 4, down-draft type

Ventilation Requirements

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ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, p. 28, Table 2

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Temperature 24°C (75°F)

At least 4 air exchanges per hour,

Relative humidity should not exceed 70%

Traffic should be controlled

Stored in a way that reduces the potential for contamination

• Do not stack heavy packages - compression

• Closed or covered cabinets recommended for the storage of seldom-used supplies

Storage Facilities

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 &A3:2012 & A4:2013, Section 8.9.2

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• 18” below the ceiling (or level of sprinkler head)

•Adequate space is needed for air circulation and fire codes

• 8-10” above the floor • Prevent contamination during cleaning

• Solid bottom shelf

• 2” for outside walls• Condensation may form on interior

surfaces of outside walls

Storage Facilities

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 &A3:2012 & A4:2013, Section 8.9.2

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ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 8.9.2

Outside shipping containers and web-edged corrugated cardboard boxes should not be allowed in the sterile storage area

• Collect dust, debris, and insects during shipping

* Photo courtesy of Department of Entomology, University of Nebraska-Lincoln.

Photographer: Jim Kalisch.

Mature Indian Meal Moth Larvae Pupating in Corrugated Cardboard*

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• Instruments should NOT be decontaminated in scrub or hand sinks

• Cleaning begins at the point-of-use

• Instruments kept moist until they are cleaned

Cleaning and Other Decontamination Processes

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 7.3, 7.4, 7.5.3.2AORN 2015 Care of Instruments. 31

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OSHA Fines Hospital for Unsafe PracticesAugust, 2014

$28,000 fine – Blood Borne Pathogen Standard violation

• “Employees are exposed to sharps injuries when contaminated disposable blades are included with reusable surgical instruments to be cleaned and sterilized.”

• “surgical employees did not always disassemble and wipe down used surgical instruments … prior to transporting in open or loosely covered basins…”

• “surgical employees placed open or loosely covered basins containing hazardous medical waste (excess blood, tissue, bone, feces, fat, etc.) and contaminated instruments into utility carts that leaked these contaminated fluids during handling ….”

United States Department of Labor. Occupational Health and Safety Administration. Inspection 974812.015 -Hallmark Health - Melrose Wakefield Hospital. https://www.osha.gov/pls/imis/establishment.inspection_detail?id=974812.015. Accessed December 13, 2014

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Manual Cleaning

Cleaning agent

• Follow manufacturer’s written IFU for water temperature and solution dilution

– Routinely monitor and document

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Water quality must meet the manufacturers’ requirements

Water quality helps:• Prolong the life of instruments

• Minimize risk of infection

Water impurities• Stains on instruments

• Negative impact disinfectants

• Affect steam quality (wet packs)

• Impacts effectiveness and life span of cleaning equipment

Water Quality

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 7.5.4

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TODAY Investigates: Dirty surgical instruments a growing problem in the OR 2/22/2012

Filthy Surgical Instruments: The Hidden Threat in America’s Operating Rooms

2009 rotator cuff repair and 7 other joint surgery patients

– Arthroscopic shaver & inflow/outflow cannula

– MFR updated cleaning IFU 10 steps

– Final step - use a digital scope to visually inspect theinsides of handpieces.

lhttp://www.iwatchnews.org/2012/02/22/8207/filthy-surgical-instruments-hidden-threat-americas-operating-roomshttp://todayhealth.today.msnbc.msn.com/_news/2012/02/22/10471434-today-investigates-dirty-surgical-instruments-a-problem-in-the-or

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Retained Human Tissue

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User Verification of Cleaning ProcessesEfficacy testing• Manual cleaning

• Visual inspection

• Protein

• ATP

• Mechanical cleaning equipment

• Tested for proper functioning:

– Before initial use,

– Weekly, preferable daily during service, and

– After major maintenance– Flexible endoscopes

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2103, Annex D

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Paper–Plastic Pouches

“Paper-plastic pouches should not be used within wrapped sets or containment devices because they cannot be positioned to ensure adequate air removal, sterilant contact, and drying. The practice of confining instruments in paper-plastic pouches and then including them in wrapped or containerized sets has not been validated as appropriate and efficacious by packaging and container Mufacturers.”*

* AORN 2014 Selection and Use of Packaging Systems for Sterilization, V No. 7ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 8.3.4

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Alternate Method to Hold Small Items

Solution – validated containment devices

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Count (Inventory) Sheets

“Count sheets should not be placed inside wrapped sets or rigid containers.

• Although there are no known reports of adverse events related to sterilized count sheets, there is no available research regarding the safety of toners and/or various papers subjected to any sterilization method. Chemicals used in the manufacturer of paper and toner ink pose a theoretical risk of reaction in some sensitized individuals.”

AORN 2015 Recommended Practices for Selection and Use of Packaging Systems for Sterilization

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Ink Transfer from Count Sheets

Shredding fibers for papers?

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Count Sheet Options

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Paper–Plastic Pouches

Appropriate Use • Contain small, lightweight,

• Low profile items (1 or 2 items)

• “Double packaging in paper-plastic pouches should not be performed without documentation from the manufacturer that the paper-plastic pouch has been validated for this use.”• FDA cleared

• If use double package, outer package must be larger – no folding

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 8.5

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Instrument Set Weight Limitation

“The total weight of instrument containment devices should not exceed 25 pounds including the contents and containment method (e.g. wrappers, rigid container systems, cassettes, organizing trays).”*

AORN 2015 Recommended Practices for Selection and Use of Packaging Systems for SterilizationANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 8.4.2

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Sterilizer Loading

Paper-plastic pouches• Stand on edge & properly spaced

• Paper side of one next to plastic side of other pouch

Wrapped instrument sets• Bottom of tray parallel to shelf

Rigid sterilization containers • Place below absorbent items

• No stacking without Mfr. recommendations

Textile Packs• Loosely loaded & Position standing on edge (layers perpendicular to shelf)

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 8.5

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All Packages Must Be Cooled

All items, including rigid sterilization containers, should remain on the sterilizer cart until adequately cooled.

Cooling time should take into account:

• Type of sterilizer

• Device design

• Temperature and humidity

• Type of packaging used

Minimum cooling 30 minutes • may require 2 hrs or more

Table top sterilizers minimum cooling 10 minutes

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, 8.8.1 & 8.8.2

Infrared temperature guns commercially available

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Sterilization Process Monitoring Tools• Physical monitors

• Chemical indicators (CI)

• Biological indicators (BI)

– Steam – weekly, preferably daily and every load containing an implant

– EtO – every load

– H2O2– daily but preferably every load

– Ozone – every load

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Sterilization Documentation

• Sterilizer identification

• Type of sterilizer and cycle used

• Lot control number

• Load contents

• Critical parameters for specific sterilization method

• Operator’s name, and

• Results of the sterilization process monitors(physical, CI, BI)

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BI and Positive BI Controls

Incubate a positive BI control each day in each incubator• Verifies

• Proper incubation conditions,

• Viability of spores ,and

• Medium sufficient to promote growth

• Positive control BI should be from same lot number as test BI

• Document control and BI lot number

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections 10.7.2.3, 10.7.3.3, 10.7.4.3

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Sterilization Process Failures

• AAMI ST79

•Decision Tree for conducting investigations of steam sterilization process failures

• BI, CI and physical monitors

• Clarify steps and provide additional guidance

•Checklist for identifying reasons for process failure

• Clarify steps and provide additional guidance

– Operator errors, – Sterilizer, or – Utilities malfunction

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ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10© 3M 2015 All Rights Reserved.

August 29, 2014, 9 Page Memo

TO: State Survey Agency Directors

FROM: Director Survey and Certification Group

Change in terminology and update of survey and certification (S&C) memorandum 09-55 regarding immediate use steam sterilization (IUSS) in surgical settings

Outmoded Term - fails to communicate time, number of steps and safeguards

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf - accessed 12/21/2014

©

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http://www.aami.org/publications/standards/ST79_Immediate_Use_Statement.pdf

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Immediate Use - Defined

• Broadly defined as…

“The shortest possible time between a sterilized items removal from the sterilizer and its aseptic transfer to the sterile field.”

• Used during the procedures for which it was sterilized

• Transported in a manner that minimized exposure to air and other environmental contaminates

• Not stored for later use, nor held for later case

©

http://www.aami.org/publications/standards/ST79_Immediate_Use_Statement.pdf

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CMS – Change in IUSS Terminology IUSS not an appropriate substitute for maintaining a sufficient

inventory of instruments.

IUSS survey procedure• Using IUSS in a manner that places patients at risk

• No to any survey questions

• Infection Control Citation

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf -accessed 12/21/2014

©

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CMS- Defining IUSS Practice

Not equivalent to “short cycle”

Not a substitute for sufficient instrument inventory

Not stored for later use

Must accomplish all steps before, during and after • In compliance with manufacturer’s IFU

• Device

• Sterilizer

• Container

Cleaning performed in a designated decontam area

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf - accessed 12/21/2014

©

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CMS - Defining IUSS Practice Con’t

Increased risks:•Contamination during transfer

•Related to wet instruments

•Potential for burns

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf - accessed 12/21/2014

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Surveyors Specific IUSS Questions

“No” to any question: warrants an infection control citation

IUSS reserved for immediate use needs (used emergently)?

Process in place to ensure IUSS is not used for: • Implants,

• Patients with known or suspected CJD,

• Loads not validated with the specific cycle, and

• Single-use devices

Instruments first cleaned and disinfected following the manufacturer’s IFU?

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf - accessed 12/21/2014

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Surveyors IUSS Questions con’t

• Evidence that all of the personnel have :– Necessary time, equipment, supplies,

– Trained and able to correctly follow the MFR IFU, and

– Competency initially verified before they undertake IUSS and periodically thereafter?

• Evidence cycle is indicated in the IFU?

• Physical monitors documented?

• Evidence sterilizer is maintained?

• Rigid container consistent with MFR IFU?

©

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf - accessed 12/21/2014

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Surveyors IUSS Questions con’t

• CI labeled for cycle by the MFR?

• CI outside each container/package • Unless CI inside package is visible

• Class 4, 5 or 6 CI in each container?

• BI labeled for cycle by MFR?

• Implantable device - BI and Class 5 CI labeled?

• All monitoring test results by trained personnel?

• Instruments aseptically transported and cooled?

• Evidence of monitoring for adherence to policy?

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf - accessed 12/21/2014

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IUSS Cycle Selection

Type of cycle• Gravity-displacement or dynamic-air-removal

• “Unless a device manufacturer specifically recommends the use of gravity cycles, dynamic air removal cycles should be the cycle of choice”. (8.6.2.1)

ANSI/AAMI ST79:20120 & A1:2012 & A2:2011 & A3:2013 & A4:2013

Say no to gravity

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POLLING QUESTION

In your facility,

A. Gravity is routinely used for IUSS

B. Dynamic air removal cycles (e.g. prevacuum) is used for IUSS unless the device IFU only states gravity

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IUSS Sterilization Documentation• Sterilizer identification

• Type of sterilizer and cycle used

• Lot control number

• Load contents

• Critical parameters for specific sterilization method

• Operator’s name, and

• Results of the sterilizationprocess monitors

• Reason for IUSS sterilization

Physical monitors

Chemical Indicators

(CI)

Biological Indicators

(BI)

AORN 2015 Recommended Practices for Sterilization

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AORN IUSS Guidelines

• Transfer immediately, using aseptic technique

• Rigid sterilization containers validated and labeled for flash-sterilization cycles:– Reduces the risk of contamination

– Protects the instruments during transportation

– Makes aseptic presentation easier

AORN 2015 Recommended Practices for Sterilization

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• Acute Inflammatory response anterior chamber of the eye

• Associated with: Contaminated solutions (BSS),

Detergent residues,

Endotoxins from overgrowth of gram-negative bacilli in ultrasonic cleaners,

Foreign matter,

Preservatives,

Impurities of autoclave steam

• “Most cases of TASS appear to result from inadequate instrument cleaning and sterilization”

(Nick Mamalis, MD, Toxic Anterior Segment Syndrome Journal of Cataract and Refractive Surgery 2006; 32:324-333.)

TASS (Toxic Anterior Segment Syndrome)64

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RP for cleaning and sterilizing intraocular surgical instruments from:• American Society of Cataract and Refractive Surgery, and

• American Society of Ophthalmic Registered Nurses

Sterilization• Should be in accordance with the IFU of the instruments and with the IFU of the sterilizer manufacturer

• Steam sterilization should be completed in accordance with published guidelines

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American Society ofOphthalmic Registered Nurses

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Reducing Risks of TASS

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Do not process with general surgical instruments

Specified concentration recommended cleaning agent

Final rinsing sterile, distilled, or deionized water

Single-use brushes should be used and disposed

Sterilize per instrument manufacturer IFU

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References and ResourcesST79 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities,

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013

Recommended Practices for Sterilization. In: AORN Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2015

Recommended Practices for Cleaning and Care of Surgical Instruments. In: AORN Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2015

CDC Guideline for Decontamination and Sterilization in Healthcare Facilities 2008

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf -accessed 12/21/2014

Mamalis N, MD, Toxic Anterior Segment Syndrome. Journal of Cataract and Refractive Surgery2006; 32:324-333

The Joint Commission. 2014 Comprehensive Accreditation Manual for Ambulatory Care (CAMAC)

Seavey R. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys, AAMI 2014

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Questions?

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